BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    QUANTUM MAVERICK MR BALLOON CATHETER

    MDR report key: 1030455 · Received April 17, 2008

    Report

    Report Number
    2134265-2008-01121
    Event Type
    Malfunction
    Date Received
    April 17, 2008
    Date of Event
    March 24, 2008
    Report Date
    March 26, 2008
    Manufacturer
    BOSTON SCIENTIFIC
    Product Code
    LOX
    PMA / PMN Number
    P860019/S167
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A PERCUTANEOUS CORONARY INTERVENTIONAL (PCI) PROCEDURE, A SHAFT BREAK OCCURRED. THE PATIENT PRESENTED WITH ANGINA PECTORIS. THE 90% STENOTIC, PROGRESSIVE, DE NOVO, DIFFUSE LESION WAS LOCATED IN THE MILDLY CALCIFIED AND MODERATELY TORTUOUS PROXIMAL/MID LEFT ANTERIOR DESCENDING (LAD) CORONARY ARTERY. ANOTHER MANUFACTURER'S 1.5MM X 15MM BALLOON CATHETER PRE-DILATED THE LESION. FOUR INFLATIONS WERE PERFORMED AT 18 ATMS FOR 5 SECONDS EACH. ANOTHER MANUFACTURER'S 3.0MM X 33MM DRUG ELUTING STENT WAS IMPLANTED IN THE PROXIMAL/MID LAD. THE 15MM X 3.0MM QUANTUM MAVERICK MONORAIL WAS INSERTED FOR POST-DILATION. UPON INSERTION OF THIS DEVICE, THE MID SHAFT BENT. UPON WITHDRAWAL, THE MIDSHAFT BROKE APPROXIMATELY 90CM FROM THE DISTAL TIP. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH ANOTHER 15MM X 3.0MM QUANTUM MAVERICK MONORAIL BALLOON CATHETER. NO PATIENT COMPLICATIONS WERE REPORTED. PATIENT STATUS US REPORTED AS "STABLE".

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 QUANTUM MAVERICK MR BALLOON CATHETER LOX CATHETERS, TRANSLUMINAL CORONARY ANGIOPLASTY, PERCUTANEOUS LOX BOSTON SCIENTIFIC 15X3.0 MM 11128994

    Patients

    Seq Age Sex Outcome Treatment
    1 50 YR 190CM| LAUNCHER EBU 3.5 6FR GUIDE CATHETER| 0.014 GUIDE WIRE| RUYIN 1.5MM X 15MM BALLOON CATHETER| CYPHER 3.0MM X 33MM DRUG ELUTING STENT| PILOT 50